Status:
UNKNOWN
Rituximab Neoadjuvant Therapy in Patients With Prostate Cancer Scheduled to Undergo Radical Prostatectomy
Lead Sponsor:
Stephen Howell, M.D.
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
There is now substantial evidence that B cells are recruited into prostate cancers by CXCL13 released by the tumor cells. B cells release lymphotoxin which drives malignant cell proliferation through ...
Detailed Description
This is an open label, single institution, pilot study of rituximab neoadjuvant therapy in patients with high risk prostate cancer scheduled to undergo radical prostatectomy. Prior to prostatectomy, p...
Eligibility Criteria
Inclusion
- Ability to understand and provide written informed consent.
- Patient has EITHER:
- A Kattan nomogram predicted probability of being disease free 5 years after surgery of \< 60%, OR
- A Gleason sum ≥ 8.
- Indicated for radical prostatectomy.
- Note: candidates for radical prostatectomy are still eligible even if they have a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Appendix A).
- Males aged ≥ 18 years.
- Adequate organ function as defined below measured within 21 days of study entry:
- Hematology:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9.0 g/dL
- White blood cell (WBC) count ≥ 3.0 x 109/L
- Biochemistry:
- Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) ≤ 2 x institution's upper limit of normal (ULN)
- Total bilirubin \<1.5 times ULN
- Serum creatinine and blood urea nitrogen (BUN)\<1.5 times ULN
- Na, K Cl, carbon dioxide (CO2), Ca, phosphate (PO4) within institutional limits
- Available prostate biopsy specimen which is evaluable for B lymphocyte count.
Exclusion
- Received prior treatment for prostatic adenocarcinoma including prior surgery (excluding TURP), radiation therapy, or chemotherapy.
- Current or past use of investigational agents within 4 weeks of study enrollment.
- Evidence of metastatic disease on cross sectional imaging or bone scan.
- History of hepatitis B or C, hepatitis immunodeficiency virus (HIV), tuberculosis or a chronic infection of any type.
- Positive test results for chronic hepatitis B infection (defined as positive HBsAg serology).
- Positive test results for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing).
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01804712
Start Date
July 1 2013
End Date
April 1 2019
Last Update
May 19 2017
Active Locations (1)
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1
Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0698